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Tailored antiplatelet strategy showed no benefit over standard dual therapy in high-risk PCI patients

Tailored antiplatelet strategy showed no benefit over standard dual therapy in high-risk PCI…
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Key Takeaway
Consider standard dual antiplatelet therapy over tailored strategies for high-risk PCI patients due to lack of benefit and higher bleeding.

This randomized clinical trial evaluated a tailored antiplatelet strategy versus standard dual antiplatelet therapy in high-risk patients with complex anatomical or clinical characteristics undergoing percutaneous coronary intervention. The tailored approach involved early escalation with low-dose ticagrelor plus aspirin for less than six months, followed by late de-escalation to clopidogrel monotherapy. The comparator group received dual antiplatelet therapy with clopidogrel and aspirin for twelve months. The primary outcome measured the composite of death from any cause, myocardial infarction, stroke, stent thrombosis, unplanned urgent revascularization, and clinically relevant bleeding at twelve months.

The trial found that the incidence of the primary composite outcome was not decreased in the tailored antiplatelet therapy group compared to the dual antiplatelet therapy group. Specifically, the tailored strategy was associated with a higher rate of clinically relevant bleeding at twelve months. The authors noted that the tailored regimen did not provide a reduction in ischemic events or bleeding risks relative to the standard dual therapy approach.

Key limitations noted by the authors include the specific context of high-risk anatomical or clinical characteristics, which may affect generalizability. The study design did not report specific funding sources or conflicts of interest. Clinicians should interpret these findings cautiously, recognizing that the tailored strategy offered no clear benefit and potentially increased bleeding risk in this specific population.

Study Details

Study typeRct
Sample sizen = 2,018
EvidenceLevel 2
Follow-up6.0 mo
PublishedMay 2026
View Original Abstract ↓
BACKGROUND AND AIMS: Limited data exist on optimal antiplatelet strategies for high-risk patients undergoing complex percutaneous coronary intervention (PCI). This study aimed to investigate the efficacy and safety of tailored antiplatelet treatment with temporal modulation of the intensity of platelet inhibition in patients undergoing complex high-risk PCI. METHODS: We randomly assigned 2018 patients with high-risk anatomical or clinical characteristics undergoing complex PCI to a tailored antiplatelet strategy with early escalation (low-dose ticagrelor at 60 mg twice daily plus aspirin <6 months) and late de-escalation (clopidogrel monotherapy >6 months) or dual antiplatelet therapy (clopidogrel plus aspirin for 12 months). The primary outcome was a composite of death from any cause, myocardial infarction, stroke, stent thrombosis, unplanned urgent revascularization, and clinically relevant bleeding (Bleeding Academic Research Consortium Type 2, 3, or 5) at 12 months. RESULTS: The mean age was 64.0 years, 22.6% had left main PCI, 19.5% had complex bifurcation PCI, 84.1% had diffuse long lesions, 93.7% had multivessel PCI, and 36.7% had medically treated diabetes. At 12 months, a primary outcome event occurred in 105 patients (10.5%) assigned to tailored antiplatelet therapy and in 89 patients (8.8%) assigned to dual antiplatelet therapy [hazard ratio, 1.19; 95% confidence interval (CI), 0.90-1.58; P = .21]. The incidence of major ischaemic events appeared to be similar in both groups. The incidence of clinically relevant bleeding at 12 months was 7.2% in the tailored-therapy group and 4.8% in the dual-therapy group (difference, 2.45% points; 95% CI, 0.37-4.53). CONCLUSIONS: Among high-risk patients undergoing complex PCI, tailored antiplatelet strategy with early escalation and late de-escalation, as compared with dual antiplatelet therapy, did not decrease the incidence of primary net adverse events at 12 months. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov number, NCT03465644.
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